MTI-301 for Metastatic or Unresectable and Refractory Solid Cancers
This study is testing a drug called MTI-301 for people with solid cancers that have spread (metastatic), cannot be removed by surgery (unresectable), and have not responded to previous treatments (refractory). MTI-301 works by blocking an enzyme called SCD1, which can help cancers grow and spread. Researchers want to find the safest and most effective dose of MTI-301, understand its side effects, and see how well it shrinks tumors or stops their growth. To join, you must be at least 18 years old and have a solid tumor that meets the criteria mentioned. The study plans to enroll 42 participants, but its current status is unclear.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of MTI-301 to find the best dose. It plans to enroll 42 participants.
- What's involved
- You would take MTI-301 by mouth once daily for 28 days in each cycle, for up to 6 cycles. You will also have CT, PET/CT, or MRI scans, and blood and tissue samples collected.
- Compensation
- Not stated in the trial record.
- Follow-up
- After your treatment ends, you will have follow-up visits every 3 months for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06911008
MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~42 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyMagnetic Resonance ImagingPositron Emission TomographyQuestionnaire AdministrationSCD1 Inhibitor MTI-301
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose
Measured over Up to 28 days (1 cycle)
+1 more outcome measured
Conditions
NCT06911008
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic in Florida
Jacksonville, Floridastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Winston Tan, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Eligibility criteria
Inclusion
Age ≥ 18 years.
Histologically or cytologically confirmed solid tumor (cancer) that is metastatic or unresectable and who are refractory to or intolerant of existing, standard-of-care therapy(ies), known to provide clinical benefit for their condition.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or evaluable disease.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 28 days prior to registration).
Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 28 days prior to registration).
Platelet count ≥ 100,000/mm\^3 (obtained ≤ 28 days prior to registration).
Total bilirubin ≤ 1.5 x upper limit normal (ULN). Patients with Gilbert's syndrome: Total bilirubin ≤ 3 x ULN (obtained ≤ 28 days prior to registration).
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 28 days prior to registration).
Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy as determined by treating investigator (obtained ≤ 28 days prior to registration).
Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula (obtained ≤ 28 days prior to registration).
Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Provide written informed consent.
Ability to complete questionnaire(s) by themselves or with assistance.
Willingness to provide mandatory blood specimens for correlative research.
Willingness to provide mandatory tissue specimens for correlative research.
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
Exclusion
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
Pregnant persons
Nursing persons
Persons who are of childbearing potential who are unwilling to employ adequate contraception.
NOTE: For the purpose of this guidance, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \[Hormonal contraception may be susceptible to interaction with the investigational medicinal product (IMP), which may reduce the efficacy of the contraception method.\]:
Oral
Intravaginal
Transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation (Hormonal contraception may be susceptible to interaction with the IMP, which may reduce the efficacy of the contraception method.):
Oral
Injectable
Implantable (Contraception methods that in the context of this guidance are considered to have low user dependency.)
Intrauterine device (IUD) (Contraception methods that in the context of this guidance are considered to have low user dependency)
Intrauterine hormone-releasing system (IUS) (Contraception methods that in the context of this guidance are considered to have low user dependency.)
Bilateral tubal occlusion (Contraception methods that in the context of this guidance are considered to have low user dependency.)
Vasectomised partner \[Contraception methods that in the context of this guidance are considered to have low user dependency. Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the women of childbearing potential (WOCBP) trial participant and that the vasectomised partner has received medical assessment of the surgical success.\]
Sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.).
Any of the following prior therapies:
Major surgery ≤ 3 weeks prior to registration
Chemotherapy ≤ 2 weeks prior to registration
Immunotherapy ≤ 3 weeks prior to registration
Radiation ≤ 2 weeks prior to registration.
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy, patients with hepatitis B and C on active treatment, or those with acute hepatitis B and C not currently on treatment.
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Clinically significant cardiac arrhythmia
Bleeding disorder
Cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
Any other conditions that would limit compliance with study requirements.
History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
Other active malignancy ≤ 3 years prior to registration.
EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
Unresolved toxicity from prior chemotherapy (subjects must be recovery to ≤ grade 1 toxicity from previous anticancer treatments or previous investigational agents).
Receiving any other investigational agent or device ≤ 14 days prior to registration.
Planning on receiving other medical, surgical, or radiological cancer treatments during the course of this study.
Evidence of untreated fluid retention at the time of registration (including, for example, peripheral edema, pleural effusion, or ascites on physical or radiological examination) or history of severe capillary leak syndrome.
Any other condition which the investigator believes would make participation in the study not acceptable.
Subjects with any active and/or symptomatic brain metastases or active primary central nervous system (CNS) and subjects with carcinomatosis meningitis are excluded.
NOTE: History of brain metastases treated by surgery and/or radiotherapy provided neurologically stable and off steroids ≥ 4 weeks prior to registration are allowed.
Grade 2 or greater neuropathy (excluding diagnosed carpal tunnel syndrome).
Use of concomitant medication that are known to be inhibitors or substrates of major CYP enzymes, CYP2C9, CYP2c19, CYP3a4, CYP2D6, CYP1A2, CYP2B6 and CYP2C8 ≤ 14 days prior to registration.
Use of concomitant medication that are known to be inhibitors or substrates of transporters ≤ 14 days prior to registration.
Corrected QT (QTc) prolongation based on QTc interval prior to registration of ≥ 470 ms using the Fridericia's formula (QTcF).
Confluent superficial keratitis, a cornea epithelial defect, a corneal ulcer or stromal opacity.
Significant electrolyte imbalance.
Significant uncontrolled congestive heart failure.
Symptomatic uncontrolled cardiac arrhythmia.
Genetic predisposition for long QT syndrome.
Subjects who are receiving concomitant QT prolonging medication.
What this trial measures
- Maximum tolerated doseUp to 28 days (1 cycle)
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT will be defined as an adverse event attributed as definitely, probably, or possibly related to MTI-301.
- Incidence of adverse eventsUp to 30 days after last dose of study treatment
Will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized. Grade 3+ adverse events will be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination.